Thoracoabdominal Aortic Aneurysm Clinical Trial
Official title:
A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair
NCT number | NCT05339061 |
Other study ID # | 803596 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | December 2029 |
The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2029 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | ---Inclusion criteria--- 1. Patient is > 18 years of age 2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study) 3. Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form 4. Patient has a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysm (Extent I-V) that meets at least one of the following: - Aortic aneurysm with diameter = 5.5cm - Aortic aneurysm with a history of growth =0.5cm in the last 6 months - Symptomatic aortic aneurysm 5. Cannot be treated with a currently available non-modified approved device 6. High risk for open surgical repair based on any of the factors below: 1. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery 2. Physiologic i. ASA Category III or higher ii. Age >70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD 7. Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft or is suitable for an iliac conduit 8. Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of = 20 mm 9. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of = 15 mm. 10. The resultant repair should preserve patency in at least one hypogastric artery. 11. Patient has a suitable non-aneurysmal proximal aortic neck diameter between 15 and 42mm 12. Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm. ---Exclusion Criteria--- -General Exclusion Criteria- 1. Patient has a mycotic aneurysm 2. Patient has a ruptured aneurysm requiring urgent or emergent repair 3. Patient has a systemic or local infection that may increase the risk of graft infection 4. Patient has a body habitus that would inhibit X-ray visualization of the aorta. 5. Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution 6. Patient has a major surgical or interventional procedure planned within +/- 30 days of the (T)AAA repair. 7. Patient is currently participating in another investigational device or drug clinical trial. -Medical Exclusion Criteria- 1. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment. 2. Patient has a known allergy or intolerance to stainless steel, polyester, polypropylene, nickel, titanium or gold. 3. Patient has uncorrectable coagulopathy 4. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina) 5. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome). 6. Patient has active malignancy with life expectancy of less than 2 years 7. Patient has a limited life expectancy of less than 2 years. 8. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations. -Anatomic Exclusion Criteria- 1. Significant occlusive disease, tortuosity or calcification that would prevent endovascular access 2. Proximal seal site with a circumferential thrombus/atheroma 3. Inability to maintain at least one patent hypogastric artery 4. Shaggy aorta 5. Patient is not amenable to a temporary or permanent open surgical or endovascular conduit |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Farber MA, Vallabhaneni R, Marston WA. "Off-the-shelf" devices for complex aortic aneurysm repair. J Vasc Surg. 2014 Sep;60(3):579-84. doi: 10.1016/j.jvs.2014.03.258. Epub 2014 May 3. — View Citation
Han SM, Tenorio ER, Mirza AK, Zhang L, Weiss S, Oderich GS. Low-profile Zenith Alpha Thoracic Stent Graft Modification Using Preloaded Wires for Urgent Repair of Thoracoabdominal and Pararenal Abdominal Aortic Aneurysms. Ann Vasc Surg. 2020 Aug;67:14-25. doi: 10.1016/j.avsg.2020.02.022. Epub 2020 Mar 20. — View Citation
O'Donnell TFX, Patel VI, Deery SE, Li C, Swerdlow NJ, Liang P, Beck AW, Schermerhorn ML. The state of complex endovascular abdominal aortic aneurysm repairs in the Vascular Quality Initiative. J Vasc Surg. 2019 Aug;70(2):369-380. doi: 10.1016/j.jvs.2018.11.021. Epub 2019 Feb 2. — View Citation
Oderich GS, Ribeiro MS, Sandri GA, Tenorio ER, Hofer JM, Mendes BC, Chini J, Cha S. Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2019 Jul;70(1):31-42.e7. doi: 10.1016/j.jvs.2018.09.063. Epub 2018 Dec 21. — View Citation
Ronchey S, Serrao E, Kasemi H, Pecoraro F, Fazzini S, Alberti V, Mangialardi N. Endovascular treatment options for complex abdominal aortic aneurysms. J Vasc Interv Radiol. 2015 Jun;26(6):842-54. doi: 10.1016/j.jvir.2015.02.021. Epub 2015 Apr 14. — View Citation
Scali ST, Neal D, Sollanek V, Martin T, Sablik J, Huber TS, Beck AW. Outcomes of surgeon-modified fenestrated-branched endograft repair for acute aortic pathology. J Vasc Surg. 2015 Nov;62(5):1148-59.e2. doi: 10.1016/j.jvs.2015.06.133. Epub 2015 Aug 5. — View Citation
Senemaud JN, Ben Abdallah I, de Boissieu P, Touma J, Kobeiter H, Desgranges P, Becquemin JP, Cochennec F. Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms. J Vasc Surg. 2020 Jun;71(6):1834-1842.e1. doi: 10.1016/j.jvs.2019.07.102. Epub 2019 Nov 7. — View Citation
Singh A, Mafeld S, Williams R, McCaslin J. Physician-Modified Fenestrated Endografts for Managing the Ruptured or Symptomatic Aortic Aneurysm: Technique Overview and Clinical Outcomes. Vasc Endovascular Surg. 2018 Nov;52(8):607-612. doi: 10.1177/1538574418789023. Epub 2018 Jul 22. — View Citation
Starnes BW, Heneghan RE, Tatum B. Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms. J Vasc Surg. 2017 Feb;65(2):294-302. doi: 10.1016/j.jvs.2016.07.123. Epub 2016 Sep 26. — View Citation
Starnes BW. Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. J Vasc Surg. 2012 Sep;56(3):601-7. doi: 10.1016/j.jvs.2012.02.011. Epub 2012 May 2. — View Citation
Sweet MP, Starnes BW, Tatum B. Endovascular treatment of thoracoabdominal aortic aneurysm using physician-modified endografts. J Vasc Surg. 2015 Nov;62(5):1160-7. doi: 10.1016/j.jvs.2015.05.036. Epub 2015 Jul 17. — View Citation
Tsilimparis N, Heidemann F, Rohlffs F, Diener H, Wipper S, Debus ES, Kolbel T. Outcome of Surgeon-Modified Fenestrated/Branched Stent-Grafts for Symptomatic Complex Aortic Pathologies or Contained Rupture. J Endovasc Ther. 2017 Dec;24(6):825-832. doi: 10.1177/1526602817729673. Epub 2017 Sep 6. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Primary Safety Endpoint (Freedom from major adverse events [MAE]) | Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke. | At 30 days or during hospitalization if this exceeds 30 days. | |
Primary | Primary effectiveness endpoint | Treatment success is defined as a composite of technical success and freedom from the following:
Aneurysm enlargement [i.e., >5mm as compared to any previous CT measure using orthogonal (i.e, perpendicular to the centerline) measurements] Aneurysm rupture Aneurysm-related mortality Conversion to open repair Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events) |
The primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year. | |
Secondary | Technical success | Technical success and the individual components of technical success:
Successful delivery Deployment at the intended implantation site Patency of all endovascular graft and stent components Absence of device deformations requiring unplanned placement of an additional device Absence of inadvertent occlusion of aorta or aortic branch vessels Successful withdrawal of delivery systems |
Procedural | |
Secondary | The individual components of the primary safety endpoint at 30 days or during hospitalization if this exceeds 30 days | All-cause mortality
Myocardial infarction Respiratory failure requiring prolonged (>24 hours from anticipated) mechanical ventilation or reintubation Renal function decline resulting in >50% reduction in baseline eGFR or new-onset dialysis Bowel ischemia requiring surgical resection or not resolving with medical therapy Major stroke Paraplegia |
At 30 days or during hospitalization if this exceeds 30 days. | |
Secondary | Follow-up outcomes | The following at each follow-up interval:
o Treatment success and the individual components of treatment success including freedom from the following: Aneurysm sac changes (i.e enlargement, shrinkage, no change) Aneurysm-related mortality Aneurysm rupture Conversion to open repair Secondary intervention for migration, type I and III endoleaks, device integrity failure (i.e., fracture), and patency-related events (i.e., device stenosis or occlusion and embolic events). Renal failure All-cause mortality Endoleaks Device integrity failure (e.g., fracture) Patency-related events (i.e., device stenosis or occlusion and embolic events) Other device-related events |
The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. |
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